Data / Medical devices / Prism, Bar, Ophthalmic
Prism, Bar, Ophthalmic (HKW): 10 FDA-registered makers in 4 countries
10 establishments in 4 countries are registered with the FDA to make Prism, Bar, Ophthalmic (product code HKW, Class 1, 21 CFR 886.1650). 0 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 2 510(k) clearances under this code, the latest on July 26, 1991, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- HKW
- Device class
- 1
- Regulation
- 886.1650
- Medical specialty
- Ophthalmic
Makers by country
| Country | Makers |
|---|---|
| United States | 4 |
| China | 3 |
| India | 2 |
| France | 1 |
Makers of Prism, Bar, Ophthalmic
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Aurora Surgical, LLC | St Petersburg, FL, United States | Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Gulden Ophthalmics | Elkins Park, PA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Lianyungang Tiannuo Optical Instrument Co., Ltd. | LIANYUNGANG Jiangsu, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Luneau Technology Operations | Pont-de-l'Arche Eure, France | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| M/S Tarun Enterprises | Prayagraj, Uttar Pradesh, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Optego Vision USA, Inc. | Tucson, AZ, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ray Vision Inc. | Lake Forest, CA, United States | Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shanghai Canton Optics Equipment Co., Ltd. | Shanghai, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Speedway | India Delhi, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Wuxi Zontai Int'l Corporation Ltd. | WUXI Jiangsu, China | Contract manufacturer, Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated July 26, 1991. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.